Health TrialsbyHealthPanel

REST4-AAA Registry

ConditionAbdominal Aortic Aneurysm
Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorRenJi Hospital

About this trial

This prospective observational study aims to investigate whether serum REST4 concentration can serve as a quantitative indicator correlated with abdominal aortic aneurysm (AAA) diameter and a predictive biomarker for AAA progression and rupture risk. Emerging evidence suggests that REST4, a splice variant of the RE-1 Silencing Transcription Factor (REST), is upregulated in vascular smooth muscle cells during AAA pathogenesis and may be released into circulation via exosomes. The study will enroll patients with asymptomatic AAA (diameter between 39-49 mm) and measure baseline serum REST4 levels, analyzing their association with morphological severity (maximum aortic diameter) and clinical outcomes (aneurysm growth rate, rupture and related mortality) through a 5-year follow-up period.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Presence of an infrarenal AAA with a maximum diameter of 39-49 mm;

Han nationality;

Between 50 years or more, no gender limit;

No mental illness;

Disqualifiers

Previous infrarenal aortic surgery;

Planned major surgery;

Known aortic dissection;

Have received any other clinical trial treatment within 1 year;

Trial population

Patients With an Abdominal Aortic Aneurysm of 39-49 mm in Diameter.

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

  • mRNA level of REST4 in serum;

    Other intervention

    1. mRNA level of REST4 in serum The mRNA expression level of REST4 was measured in serum-derived exosomes using RT-qPCR at the time of patient enrollment. 2. Computed tomography angiography (CTA) Baseline maximum internal diameter of the abdominal aortic aneurysm (AAA) was determined by CTA at enrollment. During follow-up, CTA was performed to assess the increase in maximum AAA diameter.

Treatment groups

No treatment groups listed

Trial outcomes

Primary outcomes

1

Serum REST4 Level

Quantification of serum REST4 mRNA levels in enrolled patients using RT-qPCR method

Time frame
Baseline
2

Maximal diameter of abdominal aorta

Measurement of maximal diameter of infrarenal abdominal aorta from leading edge adventitia at the anterior wall to leading edge adventitia at the posterior wall by computed tomography angiography

Time frame
Baseline
3

Change in abdominal aortic diameter

Measurement of maximal diameter of infrarenal abdominal aorta from leading edge adventitia at the anterior wall to leading edge adventitia at the posterior wall by computed tomography angiography during 5-year follow-up period.

Time frame
5 years

Secondary outcomes

1

Rates of AAA repair/rupture

Calculate the incidence of AAA repair/rupture

Time frame
5 years
2

Mortality

Calculate the mortality due to AAA rupture

Time frame
5 years

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

RenJi Hospital

Lead sponsor

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: